# K103472: Nuface Plus

- Pathway: 510(k) (Abbreviated)
- Applicant: Carol Cole Company
- Decided: Nov 7, 2011 after 348 days
- Product code: NFO (Stimulator, Transcutaneous Electrical, Aesthetic Purposes)
- Device class: 2
- Regulation: 21 CFR 882.5890
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K011935 (2001). 3 ancestors in all.
94 later devices descend from it; 10 cite it directly.
0 of 98 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072260: Nuface, Model NU-4003, Carol Cole Company (2007) Summary page 1.

## Most influential descendants
- K171821: 2 Face / Face Evolution (2018), 58 descendants of its own
- K212155: TheraFace LED (2021), 42 descendants of its own
- K223544: LED light therapy mask (FM-01, FM-02, FM-03) (2023), 39 descendants of its own
- K181008: NuFACE Trinity (2018), 22 descendants of its own
- K241857: LED Light Therapy Device (KFB290, KFB291, KFB265, KFB293) (2024), 21 descendants of its own

## Indications for use
The NOFACE® Plus Facial Toning Device is intended for facial stimulation and is indicated for over-the-counter cosmetic use (21 CFR 507 Subpart C):

Source page: https://510kreport.com/device/K103472
Methodology: https://510kreport.com/methodology